Berry Consultants has developed a powerful tool to help Biostatisticians to rapidly design, compare, and simulate both fixed and adaptive trial designs. This software tool is called FACTS — Fixed and Adaptive Clinical Trial Simulator – the most powerful, versatile, and fastest simulation tool on the market today for advanced clinical trial design.
Simulations will be the future of all clinical trials. A trial design should not be implemented before being evaluated through simulations. Without simulations all that is known about a trial is the probability of a false-positive (type-1 error) and the probability of success under a specific set of assumptions. This does not help us understand the probability of success over a range of possible "truths", nor how likely we are to get right additional decisions that depend on the trial such as selection of the best dose, identification of the best treatment population or understanding of the risk-benefit. Furthermore, without simulations we can not investigate the use of innovative designs that may allow us to learn faster, more efficiently and with better treatment of the subjects in the trial.
FACTS is a software system that helps clinical teams run those simulations and optimize their trial design. It does this by providing a suite of programs that allow most common phase 1, phase 2 and phase 3 trial types to be defined and then simulated. It incorporates many of the current leading edge trial design innovations as options so that their potential benefits for the trial under consideration can be easily assessed.
The FACTS simulation software is a fully supported, commercialized package that brings some of the most commonly used features of advanced trial designs straight to the statistician’s computer via a powerful user interface. The tool allows a rapid stepwise design of both fixed and adaptive trials. Its enables biostatisticians to easily select between options and rapidly simulate multiple scenarios so that different design features can be evaluated, optimal parameter settings found and the expected performance of the planned trial explored.
FACTS provides access to better phase 1, 2 and 3 trial designs, that can save millions of dollars, months of development time and support better clinical development decisions.
An overview about FACTS can be downloaded here.
For more information about FACTS and/or a demo, please contact us.